rope01 rope02

Clinical Trials

Turning Point Therapeutics is a clinical-stage biopharmaceutical company currently enrolling eligible patients in TRIDENT-1, a study of repotrectinib in patients with certain solid tumor cancers.

TRIDENT-1

A Study of Repotrectinib (TPX-0005) in Patients with Advanced Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Rearrangements

TRIDENT-1 is enrolling patients in a Phase 1/2 multi-center trial evaluating our lead drug candidate, repotrectinib, for the treatment of patients with ROS1+ advanced non-small cell lung cancer (NSCLC) as well as patients with ROS1+, NTRK+ or ALK+ advanced solid tumors. Repotrectinib is being assessed for safety, tolerability, pharmacokinetics and antitumor activity.

Tumors with ROS1, NTRK and ALK gene mutations or rearrangements have a higher likelihood of developing resistance to existing targeted therapies. In many cases, these mutations prevent existing treatments from targeting and treating the tumor as effectively. Repotrectinib is designed to be smaller and less bulky than existing targeted therapies, and may circumvent some the resistance mechanisms found in tumors with ROS1, NTRK and ALK mutations.

A Precision Oncology Approach

The TRIDENT-1 study will be using next-generation sequencing to determine whether tumor cells carry the genetic mutations of interest: ROS1, NTRK, ALK. These genetic tests help identify patients with tumors that are most likely to respond to treatment.

Where are the trials located?

TRIDENT-1 study locations are currently open. Visit the TRIDENT-1 page at www.ClinicalTrials.gov for a list of active sites.

How can I learn more?

Visit www.ClinicalTrials.gov
If you have questions about our clinical trials, you can contact us via email at clinical@tptherapeutics.com or by phone at 858-276-0005.

Compassionate Use

Compassionate use, also called “expanded access,” provides a pathway for a physician to request access for their patients to investigational medicines that are being tested but not yet approved. Turning Point Therapeutics is committed to discovering and developing oncology therapies that address high unmet medical needs and improve the lives of patients. Our clinical programs are designed to evaluate the potential risks and benefits of our investigational medicines and to obtain regulatory approval. We believe it is through clinical trials and successful regulatory approval that potential medicines can be made available to the greatest number of patients who may benefit. In exceptional circumstances, we consider physician requests for compassionate use of our investigational medicines outside of ongoing clinical trials. These requests must meet the following criteria:

  • The patient is not eligible for any current clinical trial
  • There are no other treatment options available
  • Sufficient evidence is available to support that the potential benefit of receiving access to the investigational medicine outweighs the potential risks
  • The use of an investigational medicine does not compromise its development

Patients interested in obtaining access to a Turning Point investigational medicine must do so via their physician. Physician requests can be submitted: compassionate@tptherapeutics.com.

You can learn more about our clinical trials at: ClinicalTrials.gov

This policy is subject to change.